INFANTS SILAPAP - acetaminophen solution/ drops 
Silarx Pharmaceuticals, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.


Infant's Silapap Drops

Active Ingredient: Acetaminophen 80 mg (in each 0.8 mL)

Purpose: Fever reducer/pain reliever



■ reduces fever

■ relieves minor aches and pains due to:
   ■the common cold ■flu ■toothaches ■sore throat ■headaches 


Liver warning:
This product contains acetaminophen. Severe liver damage may occur if your child takes:

Sore throat warning: if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

Ask a doctor before use if your child has liver disease.
Ask a doctor or pharmacist before use if your child is taking the blood thinning drug warfarin.

When using this product

Stop use and ask a doctor if

■ new symptoms occur
■ redness or swelling is present
■ pain gets worse or lasts for more than 5 days
■ fever gets worse or lasts for more than 3 days.

These could be signs of serious condition.

Keep out of reach of children.

Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away, (1-800-222-1222). Quick medical attention is critical even if you do not notice any signs or symptoms.


this product does not contain directions or complete warnings for adult use
do not give more than directed (see overdose warning)
■ find right dose on chart, if possible use weight to dose; otherwise, use age
■ use only enclosed dropper designed for use with this product, do not use any other dosing device
■ fill to dose level
■ dispense liquid slowly into child's mouth, toward inner cheek
■ may be given alone or mixed with formula, milk, juice etc.
■ If needed, repeat dose every 4 hours
■ do not give more than 5 times in 24 hours
■ Replace dropper tightly to maintain child resistance

Weight (lb) Age (yr)
Dose (mL)
under 24
under 2 years
ask a doctor
2-3 years
 1.6 mL (0.8 + 0.8 mL)

For accurate dosing follow dosing instructions using the enclosed dropper. Fill dropper to 0.8 mL or prescribed level, and dispense with a single firm squeeze of the dropper bulb.

Other information
Store between 20° - 25°C (68° - 77°F)

Inactive ingredients

citric acid, FD&C yellow no. 6, cherry flavor, methylparaben, saccharin sodium, sodium benzoate, sodium citrate, propylene glycol and purified water.



Manufactured by:

Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave.
Carmel , NY 10512


acetaminophen solution/ drops
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54838-145
Route of Administration ORAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 80 mg  in 0.8 mL
Inactive Ingredients
Ingredient Name Strength
anhydrous citric acid (UNII: XF417D3PSL)  
FD&C yellow no. 6 (UNII: H77VEI93A8)  
methylparaben (UNII: A2I8C7HI9T)  
saccharin sodium dihydrate (UNII: SB8ZUX40TY)  
sodium benzoate (UNII: OJ245FE5EU)  
sodium citrate (UNII: 1Q73Q2JULR)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
Product Characteristics
Color      Score     
Shape Size
Flavor CHERRY (wild cherry) Imprint Code
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54838-145-15 15 mL in 1 BOTTLE, DROPPER
2 NDC:54838-145-30 30 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part343 04/01/1997
Labeler - Silarx Pharmaceuticals, Inc (161630033)

Revised: 6/2014
Document Id: b6145102-e475-48cd-8809-8115a35f2a78
Set id: 4c4ae7af-eacd-4b15-860c-d08305fce8e4
Version: 14
Effective Time: 20140627
Silarx Pharmaceuticals, Inc